International cooperative Phase II trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children = 3 years and adolescents < 18 years. - HIT-HGG-2007

Phase 1

• Conditions: 1st line therapy of newly diagnosed, previously untreated high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents = 3 years and < 18 years; MedDRA version: 19.1 Level: PT Classification code 10002224 Term: Anaplastic astrocytoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: LLT Classification code 10030288 Term: Oligodendroglioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: PT Classification code 10066254 Term: Gliomatosis cerebri System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: PT Classification code 10026659 Term: Malignant oligodendroglioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: PT Classification code 10018340 Term: Gliosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: PT Classification code 10065443 Term: Malignant glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1 Level: PT Classification code 1

• Registration Number: EUCTR2007-000128-42-DE
• Lead Sponsor: Martin-Luther-University Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 456

Inclusion Criteria

•Newly diagnosed, previously untreated high grade glioma with central neuropathological review including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic mixed glioma/anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV)

•Newly diagnosed, previously untreated diffuse intrinsic pontine glioma of all tumour grades or without histology when confirmed by central neuroradiological review

•Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuropathological review and neuroradiological review

•Patient aged 3 years and older but under 18 years at time of diagnosis

•Written informed consent of the patient and/or the patient’s parents or legal guardian according to national laws

Are the trial subjects under 18? yes
Number of subjects for this age range: 456
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pre-treatment differing from study protocol

•Known hypersensitivity or contraindication to study drugs and/or dacarbazine

•Prior chemotherapy or radiotherapy which prevents adequate performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary malignant glioma after a previous malignant brain tumour, e.g. medulloblastoma, supratentorial PNET. If previous treatment does not prevent the adequate performance of the outlined treatment protocol patients with secondary malignant glioma will be eligible for the present trial.

•Other (simultaneous) malignancies

•Pregnancy and / or lactation

•Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)

•Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial

•Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)

•Severe concomitant diseases (e.g. immune deficiency syndrome)

•Known HIV positivity

•Country-specifically very young patients may be excluded to comply with national laws or formal insurance requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified